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Laboratory Corporation of America Holdings

Labcorp

Labcorp (NYSE: LH) is a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions.

Lobbying Activity

Meeting with Ann-Sofie Ronnlund (Cabinet of Commissioner Ekaterina Zaharieva)

7 Nov 2025 · Life sciences

Response to Targeted revision of the EU rules for medical devices and in vitro diagnostics

6 Oct 2025

Labcorp is a global leader in innovative laboratory services and the market leader in central laboratory (CL) testing services. We have a strong R&D footprint in Europe, and our CL in Switzerland analyses samples from clinical trial patients in EMEA. A CL is a laboratory where specimen samples from clinical trial patients are analysed to guide decisions on clinical trials and patient management. Biotech and pharma rely on CLs to provide the highest level of global data consistency, crucial to multinational clinical trials. Issue: By not recognising CLs as health institutions (HIs), regulators fail to recognise that CLs are key for conducting EU clinical trials, supporting patient care and treatment, and promoting public health. Revisions must provide a high-quality pathway for all laboratories to continue performing specialised diagnostic testing in clinical trial settings, to the benefit of EU patients and innovation. Ask 1) CLs must be able to provide diagnostic testing for clinical trials in a way that is compliant and fit-for-purpose, to the benefit of EU patients and innovation. Solution 1.a: (i) Recognise CLs as HI per IVDR Article 5(5) and (ii) support the recognition of HIs established in certain other European countries. (i) Like hospital laboratories or other institutions with HI designation, CLs must be able to develop and use (non-commercialised) in-house devices to address the clinical trials specific needs or targeted patient group, for which often no devices are commercially available. CLs must also be able to make minor modifications to CE-marked devices for in-house use when necessary to meet the clinical trials specific needs without becoming the manufacturer, to the benefit of patients (e.g., extended stability allows patients living away from sites to participate in trials). (ii) CLs follow stringent quality procedures to ensure accurate and precise results set by national law and international standards, as applicable. Therefore, HI designation can and must be applied to certain non-EU-based CLspivotal for the functioning of EU clinical trialslocated in countries where an MRA covers IVD-related regulatory/oversight aspects (e.g., Switzerland) or established in countries deemed by the EU Commission to apply essentially equivalent requirements as EU-based HIs. Solution 1.b (if solution 1.a is not deemed feasible): Amend IVDR to allow CLs when developing IVDs for use in clinical trials to benefit from Article 5(5), but without being recognised as HIs. Labcorp acknowledges that designation of HIs may have certain implications at the Member State level. However, as per point (i), CLs ability to develop in-house devices and make modifications to CE-marked devices is pivotal to address the specific needs of trials in the EU. These IVDs are not commercialised, and their utility mirrors those developed by HIs. Therefore, if CLs cannot be deemed as HIs, a separate provision must allow CLs to benefit from the same exemption as HIs, notably CE marking and performance studies (PS), when developing IVDs for use in clinical trials. This will ensure timely access to high-quality IVDs in EU clinical trials. Ask 2) Simplify rules for IVDs used in clinical trial settings. Solution: Simplify PS requirements for IVDs used in clinical trials. IVDs, e.g., CDx, must collect data from PS for CE marking. However, PS requirements are burdensome on all parties involved (as evidenced by numerous EC and EMA projects and stakeholder comments, for example, EUCOPEs comments to the call for evidence). Not only is the process complex, it is also fragmented across MSs, creating uncertainties and leading to fewer IVDs at the detriment of patient management. PS requirements for IVDs need to be simplified, notably, through the application of a risk-based approach.
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Response to EU rules on medical devices and in vitro diagnostics - targeted evaluation

19 Mar 2025

Labcorp is a global leader in diagnostics and drug development. It also has a presence across the EU, with facilities in Belgium and Germany and commercial staff across EU Member States. In Europe, we commercialise genomics assays and companion diagnostics (CDx). In addition, our central laboratory in Geneva, Switzerland, is the market leader in performing tests for patients enrolled in clinical trials in the EU. To provide safe patient care and treatment while fostering a competitive and innovative clinical trial environment in the EU, the regulatory framework needs to provide the clarity and support needed for stakeholders to navigate the requirements. Two key examples concern, respectively: 1) the provisions that govern the use of in-house devices (IVDs developed and used in the same laboratory, not commercialised and marketed) and 2) the framework for CDx. 1) Central laboratories develop and use a large share of the in-house devices that serve EU clinical trials to address the specific needs of targeted patient groups for which commercially available devices do not exist or do not completely fulfil testing needs. A central laboratory is a laboratory where samples drawn from clinical trial patients are analysed to guide decisions on clinical trial and patient management. Its location is not tied to the patient populations location: sponsors rely on central laboratories to provide consistent and reliable testing for the same clinical trial conducted across multiple jurisdictionsindeed, a major proportion of in-house devices serving EU clinical trial patients are developed and used by central laboratories in Switzerland, UK, and the U.S. Central laboratories are key to ensuring patients care and treatment and promoting public healththe primary purpose of a health institution (HI) as per the IVDR. In this view, central laboratories consider themselves HIs as defined by the IVDR. To meet patients needs, the regulatory framework should be updated to account for the essential role of in-house devices and the conditions in which they are developed and used. This necessitates that: i) the IVDR, specifically IVDR Article 5(5), and MDCG guidance, clearly identify central laboratories within the scope of the IVDR HI definition, to ensure that they keep providing patient health services in a compliant but flexible regulatory environment and clinical trial sponsors have access to the tests needed to perform clinical trials in the EU; ii) certain non-EU central laboratories be allowed to operate under the IVDR HI definition, provided they fulfil the other applicable requirements and/or fulfil the EU HI requirements under IVDR Article 5(5), to ensure that they keep providing specialised testing to the benefit of EU patients. 2) While the IVDR, CTR, and related guidelines set some expectations for CDx with an associated medicine, the framework remains unnecessarily complex and subject to multiple administrative obstacles, as evidenced in EMAs COMBINE report. Further guidance, clarification, and a more agile regulatory process are required, including implementing some of the elements outlined in the EMAs strategy for its COMBINE programme. In addition, measures are needed to ensure that the EU is an attractive region for developing novel technologies to benefit patients and healthcare systems, particularly to further simplify the performance study application (PSA) requirements for CDx. Currently, CDx-related PSAs require the submission of documentation under the purview of the investigational medicinal products developer under the corresponding clinical trial application (CTA). In combined CDx studies, these documents belong to the clinical trial sponsor, who does not have the ability to author any changes that may be asked by the competent authority reviewing the PSA, which may cause challenges for the review. Further clarity and a defined review pathway are necessary for CDx and the corresponding therapeutic treatment.
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